Saxenda® demonstrated significant improvements in cardiometabolic risk factors over three years compared with placebo

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Oral Presentation# OR36-1

Today, new data from the three-year part of the phase 3a SCALE(TM)
(Satiety and Clinical Adiposity - Liraglutide Evidence) Obesity and
Prediabetes trial were presented at the Endocrine Society's 98th
Annual Meeting and Expo (ENDO 2016). The three-year part of the trial
(n=2,254 adults with obesity or who were overweight with
comorbidities and had prediabetes at baseline), data demonstrated
that 160 weeks of treatment with Saxenda® (liraglutide 3 mg)
(n=1,505) in combination with a reduced-calorie diet and increased
physical activity resulted in significant improvements in
cardiometabolic risk factors (such as blood pressure and cholesterol)
compared with placebo (reduced-calorie diet and increased physical
activity alone) (n=749).[1]

At week 160, individuals treated with Saxenda® had lost more
weight (6.1%) than those treated with placebo (1.9%) (estimated
treatment difference [ETD] -4.3% [95% CI -4.9; -3.7], p<0.0001).[1]
In addition, treatment with Saxenda® achieved results beyond weight
loss including improvements in some cardiometabolic risk factors such
as blood pressure and cholesterol. At week 160, participants
randomised to treatment with Saxenda® experienced a greater reduction
in systolic blood pressure compared with placebo (ETD -2.8 mmHg
[-3.8; -1.8], p<0.0001). Those treated with Saxenda® also experienced
greater improvements in triglycerides (ETD -6% [-9; -3], p=0.0003)
and total cholesterol levels (ETD -2% [-3; 0], p=0.03) compared with
placebo. Additionally, people treated with Saxenda® showed a greater
reduction in mean waist circumference compared with placebo (ETD -3.5
cm [-4.2; -2.8]).

"We know that weight loss of as little as 5 to 10% in people with
obesity can have an impact on cardiometabolic risk factors," said Dr
Ken Fujioka, Scripps Clinic, San Diego, California, US and a
SCALE(TM) clinical trial investigator. "This is currently the longest
weight-management trial with Saxenda®, and the observed improvements
in blood pressure, lipids and waist circumference at three years are
encouraging."

In addition, the three-year part of the SCALE(TM) Obesity and
Prediabetes trial met its primary endpoint, demonstrating that
continued treatment over three years with Saxenda®, in combination
with a reduced-calorie diet and increased physical activity, delayed
the onset of type 2 diabetes compared with placebo.[1]

Aligned with previous trials, during treatment with Saxenda®, mean
pulse rate was increased (ETD +2 beats/min [+1.2; +2.7], p<0.0001).
Saxenda® was generally well tolerated, and observed side effects were
in line with previous trials.[2] Over 160 weeks, reports of serious
adverse events were higher in those treated with Saxenda® compared
with placebo (15.1% vs 12.9%). Rates of gallbladder-related adverse
events and confirmed acute pancreatitis were low, but more frequent
in those treated with Saxenda® (2.9 events per 100 patient-years of
observation [PYO] and 0.29/100 PYO, respectively) vs placebo (1.2/100
PYO and 0.13/100 PYO, respectively). The frequency of adjudicated
major adverse cardiovascular events was low, and comparable in those
treated with Saxenda® and placebo (0.19 vs 0.20 events/100 PYO).[1]

About obesity

Obesity is a disease[3] that requires long-term management. It is
associated with many serious health consequences and decreased
life-expectancy.[4],[5] Obesity-related comorbidities include type 2
diabetes, heart disease, obstructive sleep apnoea (OSA) and certain
types of cancer.[4],[6],[7] It is a complex and multi-factorial
disease that is influenced by genetic, physiological, environmental
and psychological factors.[8]

The global increase in the prevalence of obesity is a public
health issue that has severe cost implications to healthcare systems.
In 2014, 13% of adults, or approximately 600 million adults, were
living with obesity.[9]

About Saxenda®

Saxenda® (liraglutide 3 mg) is a once-daily glucagon-like
peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring
human GLP-1, a hormone that is released in response to food
intake.[10] Like human GLP-1, Saxenda® regulates appetite by
increasing feelings of fullness and satiety, while lowering feelings
of hunger and prospective food consumption, thereby leading to
reduced food intake. As with other GLP-1 receptor agonists, Saxenda®
stimulates insulin secretion and lowers glucagon secretion in a
glucose-dependent manner.[2] Saxenda® was evaluated in the SCALE(TM)
(Satiety and Clinical Adiposity - Liraglutide Evidence) phase 3
clinical trial programme.

Saxenda® is approved in the US as an adjunct to a reduced-calorie
diet and increased physical activity for chronic weight management in
adults with obesity (BMI of >=30 kg/m2) or who are overweight (BMI of
>=27 kg/m2) in the presence of at least one weight-related comorbid
condition (e.g. hypertension, dyslipidaemia, type 2 diabetes).[11]

In the EU, Saxenda® is indicated as an adjunct to a
reduced-calorie diet and increased physical activity for weight
management in adult patients with an initial BMI of >=30 kg/m2
(obese), or >=27 kg/m2 to <30 kg/m2 (overweight) in the presence of
at least one weight-related comorbidity such as dysglycaemia
(prediabetes or type 2 diabetes mellitus), hypertension,
dyslipidaemia or obstructive sleep apnoea.[2]

Guidance is given in the label that treatment with Saxenda® should
be discontinued if a specific threshold of weight loss has not been
achieved after a certain period of time.

About the SCALE(TM) clinical development programme

Novo Nordisk's phase 3 development programme, called SCALE(TM),
investigates liraglutide 3 mg for weight management. SCALE(TM)
(Satiety and Clinical Adiposity - Liraglutide Evidence) consists of
four, placebo-controlled, multinational trials called: SCALE(TM)
Obesity and Prediabetes, SCALE(TM) Diabetes, SCALE(TM) Sleep Apnoea
and SCALE(TM) Maintenance. The trials include more than 5,000 people
who are overweight (BMI >=27 kg/m2) with comorbidities such as
hypertension, dyslipidaemia, obstructive sleep apnoea (OSA), or type
2 diabetes or who have obesity (BMI >=30 kg/m2), with or without
comorbidities. The studies all involved a reduced-calorie diet and
increased physical activity.

Key results from all trials in the SCALE(TM) clinical development
programme have been published, with further data expected to be
presented and published throughout 2016.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90
years of innovation and leadership in diabetes care. This heritage
has given us experience and capabilities that also enable us to help
people defeat other serious chronic conditions: haemophilia, growth
disorders and obesity. Headquartered in Denmark, Novo Nordisk employs
approximately 41,000 people in 75 countries and markets its products
in more than 180 countries. For more information, visit
novonordisk.com (http://www.novonordisk.com/), Facebook
(http://www.facebook.com/novonordisk), Twitter
(http://www.twitter.com/novonordisk), LinkedIn
(http://www.linkedin.com/company/novo-nordisk), YouTube
(http://www.Youtube.com/novonordisk)

Further information

Media:

Katrine Sperling

+45-4442-6718

krsp@novonordisk.com

Åsa Josefsson

+45-3079-7708

aajf@novonordisk.com

Investors:

Peter Hugreffe Ankersen

+45-3075-9085

phak@novonordisk.com

Melanie Raouzeos

+45-3075-3479

mrz@novonordisk.com

Daniel Bohsen

+45-3079-6376

dabo@novonordisk.com

Kasper Veje

+45-3079-8519

kpvj@novonordisk.com

References

1. Fujioka K GF, Krempf M, le Roux C, Vettor R, Shapiro Manning
L, Lilleøre S, Astrup A. Liraglutide 3.0 mg Reduces Body Weight and
Improves Cardiometabolic Risk Factors in Adults with Obesity or
Overweight and Prediabetes: the SCALE Obesity and Prediabetes
Randomized, Double-blind, Placebo-controlled 3-year Trial. ENDO 2016

2. EMA. Saxenda® (liraglutide 3 mg) Summary of Product
Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/do
cument_library/EPAR_-_Product_Information/human/003780/WC500185786.pd
f . Last accessed: February 2016.

3. American Medical Association A. Declaration to classify
obesity as a disease. Annual Meeting Report. 19 June 2013.

4. Guh DP, Zhang W, Bansback N, et al. The incidence of
co-morbidities related to obesity and overweight: a systematic review
and meta-analysis. BMC Public Health. 2009; 9:88.

5. Peeters A, Barendregt JJ, Willekens F, et al. Obesity in
adulthood and its consequences for life expectancy: a life-table
analysis. Annals of Internal Medicine. 2003; 138:24-32.

6. Gami AS, Caples SM, Somers VK. Obesity and obstructive sleep
apnea. Endocrinology and Metabolism Clinics of North America. 2003;
32:869-894.

7. Whitlock G, Lewington S, Sherliker P, et al. Body-mass index
and cause-specific mortality in 900 000 adults: collaborative
analyses of 57 prospective studies. Lancet. 2009; 373:1083-1096.

8. Wright SM, Aronne LJ. Causes of obesity. Abdominal Imaging.
2012; 37:730-732.

9. WHO. Obesity and Overweight Factsheet no. 311. Available at:
http://www.who.int/mediacentre/factsheets/fs311/en/ . Last accessed
February 2016.

10. Knudsen LB, Nielsen PF, Huusfeldt PO, et al. Potent
derivatives of glucagon-like peptide-1 with pharmacokinetic
properties suitable for once daily administration. Journal of
Medicinal Chemistry. 2000; 43:1664-1669.

11. FDA. Saxenda® (liraglutide 3 mg) US Prescribing Information.
Available at: http://www.novo-pi.com/saxenda.pdf Last accessed:
February 2016.

ots Originaltext: Novo Nordisk A/S
Im Internet recherchierbar: http://www.presseportal.de